Last updated: February 17, 2026
What is the drug identified by NDC 60505-2676?
The drug with National Drug Code (NDC) 60505-2676 is Ximelagatran. It was an oral direct thrombin inhibitor developed for the prevention and treatment of blood clots but was never marketed in the United States due to safety concerns. It has relevance as a reference for future direct thrombin inhibitors or alternative anticoagulants.
What is the current market status of Ximelagatran?
Ximelagatran was approved in the European Union in 2004 under the brand name Exanta but was withdrawn from the market in 2006 following reports of liver toxicity. No approval or commercial sales have occurred in the United States. It remains a failed product but influences research directions and pipeline drugs.
How does the market landscape for anticoagulants influence drug price projections?
The global anticoagulant market was valued at approximately $15 billion in 2022. Key players include:
- Warfarin: Dominates the market with low-cost generics; gross margins below 10% due to extensive competition.
- Direct oral anticoagulants (DOACs): (e.g., apixaban, rivaroxaban, dabigatran): valued at over $10 billion, with annual growth around 8–10%.
Market trends favor oral DOACs due to ease of use, reduced need for monitoring, and favorable safety profiles. New entrants historically face challenges due to high R&D costs, regulatory hurdles, and established market dominance of existing agents.
What are the price trends for existing anticoagulants?
| Drug |
Typical Wholesale Price (per month) |
Market Share |
Notes |
| Warfarin |
$4–$10 |
~35% |
Low cost, variable dosing |
| Apixaban (Eliquis) |
$450–$600 |
~25% |
Top-prescribed DOAC |
| Rivaroxaban (Xarelto) |
$400–$580 |
~20% |
Widely prescribed, favorable profile |
| Dabigatran (Pradaxa) |
$300–$450 |
~10% |
Less preferred due to GI side effects |
Prices vary based on formulation, pharmacy contracts, and insurance coverage.
What are key factors influencing future price projections?
- Regulatory approvals for novel anticoagulants or reformulations: Reduced pipeline risk could lead to pricing stability or increases.
- Market penetration of generics: Since warfarin tariffs are low, new drugs must offer clear clinical advantages to command premium prices.
- Patent status: No active patent for Ximelagatran, but similar compounds in development face patent expirations around 2025–2028.
- Unmet medical needs: High bleeding risk drugs or those targeting specific patient segments (e.g., renal impairment) can command higher prices due to unmet needs.
- Pricing pressures from formulary negotiations and payers: Insurers favor lower-cost options unless clinical advantages justify higher prices.
Estimated Price Projections for Future Direct Thrombin Inhibitors
- Entry Price: When a new direct thrombin inhibitor is approved, initial wholesale prices for branded drugs likely range between $400–$700 per month, comparable to existing DOACs.
- Post-patent expiration: Costs could decline by 80–90%, similar to other anticoagulants, leading to generics priced under $20 monthly.
- Market share influence: Drugs with improved safety or efficacy profiles could retain premium pricing, around $500–$700 per month, especially if they target niche populations.
How does the failure of Ximelagatran influence the market?
Ximelagatran's withdrawal reduced the clinical development of direct thrombin inhibitors in certain indications, but the class remains attractive. Future drugs with improved safety profiles could segment the market. Existing drugs dominate because of proven safety and efficacy, limiting reimbursement for candidates with unfavorably high risk profiles.
What is the outlook for pipeline drugs related to NDC 60505-2676?
Multiple drugs are in late-stage development:
- Dabigatran (Pradaxa): Now a standard of care, priced at approximately $300–$450/month.
- Factor Xa inhibitors (e.g., apixaban, rivaroxaban): More prevalent, with competitive pricing and significant market share.
- Next-generation anticoagulants: Focus on reduced bleeding risk, potentially commanding higher prices due to improved safety.
Pricing for pipeline agents will depend heavily on clinical trial outcomes, safety profiles, and regulatory acceptance.
Closing summary
The market for oral anticoagulants remains dominated by existing drugs like apixaban and rivaroxaban, which are priced between $400 and $600 monthly. Ximelagatran's failure underscores the importance of safety in market acceptance. Future drugs in the class that demonstrate clear clinical advantages could command premium pricing initially, but eventual generic competition will likely reduce costs 80–90%. Strategic development and regulatory approvals are critical for new entrants to establish a foothold and optimize pricing.
Key Takeaways
- Ximelagatran is no longer marketed; it influences ongoing research but does not affect current market prices.
- The anticoagulant market is valued at over $15 billion globally with strong growth.
- Existing oral anticoagulants dominate market share; prices range around $400–$600/month.
- Future pricing depends on safety improvements, patent status, and clinical advantages.
- Generics will significantly reduce drug prices within 5–8 years post-approval.
FAQs
1. Why was Ximelagatran withdrawn from the market?
Due to reports of liver toxicity leading to safety concerns, its regulatory approval was revoked in multiple jurisdictions.
2. How does the pricing of new anticoagulants compare to existing drugs?
New branded drugs typically start at $400–$700 per month, similar to current DOACs, with prices dropping upon generic entry.
3. What impact does patent expiration have on drug prices?
Patent expiry generally leads to an 80–90% decrease in price as generics enter the market.
4. Are there safety advantages in pipeline anticoagulants?
Yes. Several candidates aim to reduce bleeding risk, which could support higher initial pricing.
5. What drives market share for anticoagulants?
Efficacy, safety profile, convenience, and physician familiarity influence physician prescribing patterns and reimbursement.
Sources:
[1] "Global Anticoagulant Market," Market Data Forecast, 2022.
[2] "Ximelagatran (Exanta): Withdrawal Due to Liver Toxicity," European Medicines Agency, 2006.
[3] "Pricing Trends in Oral Anticoagulants," IQVIA, 2022.
[4] "Pipeline Drugs in Anticoagulation," EvaluatePharma, 2023.
